>7,500
Products Across 10 Therapeutic Categories
68
Products on WHO List of Prequalified Products
Manufactured ~5 Billion
ARV Tablets and Capsules
12
Global
R&D Centers
of the ~22M HIV+ Patients on Treatment Depend on one of our Products
of the World’s HIV+ Children on Treatment Depend on one of our Products
Mylan’s foundation and core business model are focused on providing access to medicine. We are convinced that meeting this challenge requires a consistent and sustainable commitment. To reinforce that commitment, we have developed access objectives and key performance indicators (KPIs) that flow from our mission statement and describe how we have and will continue to operate universally to fulfill our aim of providing high quality medicines to billions of patients around the world. Our value chain details how our robust research and development, manufacturing, supply chain and market outreach capabilities help us to continually focus on meeting the needs of patients today while also anticipating their needs in the years to come.
To maximize our ability to meet patients’ needs across a variety of health conditions, we focused in 2019 on 10 therapeutic categories. We serve an industry leadership role in many of these areas, with each category containing not just one or two products, but often hundreds of products in a broad range of dosage forms, formulations and delivery systems that allow physicians and patients to tailor care for optimal treatment. In 2019, we supplied more than 7,500 products and reached more than 165 countries and territories, including 88.5% of low- and lower-middle-income countries2 at an average selling price of 18¢ per dose. Our diverse portfolio and work in the areas of infectious disease and women’s health particularly support our commitment to the Sustainable Development goals.
Our achievements in biosimilars help patients around the world unlock greater access to more affordable care for many of the world’s most devastating diseases. Mylan has regulatory approvals for biosimilars in more than 85 countries.
Pharmacovigilance
Our pharmacovigilance program and Global Policy on Product Safety provide the framework to help ensure patients are using our medicine safely and appropriately. We conduct regular audits of our products, address potential risks and conduct training that reinforces our commitment to product safety.
Appropriate Use
We help patients use their medicines appropriately and better adhere to their prescriptions. Online portals, websites, digital solutions for healthcare providers and mobile apps that track symptoms or remind patients to refill their prescriptions are just a few ways we help improve the health of patients around the world.
We know that what we do directly impacts the health and well-being of patients.
All of Mylan’s sites are regulated and inspected by national health authorities from the markets where we sell. The health authority inspections provide extensive external certification and authorization of Mylan sites for further production and marketing. We constantly review our products, processes and facilities throughout our network and work closely with external health authorities to ensure transparency with emerging information, including shortages, adverse event reporting of other manufacturers’ products, development of new scientific and testing criteria and evolving regulatory and manufacturing expectations everywhere we operate. We continuously learn from these interactions as scientific, technology and regulatory expectations continue to evolve.
In addition to Good Manufacturing Practices (GMP), we apply all other applicable quality guidelines and practices, including, for example: Eudralex, Falsified Medicines Directive, ICH Quality Guidelines, WHO GMP, Food and Drug Administration Safety and Innovation Act (FDASIA) and the EU Excipient Risk Assessment for ascertaining GMP for excipients of medicinal products for human use.
Risk assessment is central to our approach to ensuring quality in our facilities around the world. We promote regular self inspection of our sites and conduct annual audits. Our Quality Council Program drives appropriate quality management action by tracking quality issues; analyzing metrics to identify trends, issues and risks; examining key performance indicators; and providing clear and accurate data analysis. Externally, we apply an audit schedule based on business prioritization, cyclical audit requirements of facilities, key launches and historical regulatory inspection performance.
We are also committed to maintaining a high quality supply chain which includes a strong focus on fighting falsified medicine and state-of-the art serialization technology.
R&D supports the expansion of our portfolio to treat non-communicable and communicable conditions.
While we continue our core generic drug development, we are also leveraging our internal capability to develop additional complex and differentiated products. Focus areas include biosimilars, complex injectables, topicals and other important products as we continue to identify unmet needs and create solutions to address them. We’ll also focus on new chemical entities and the development of new delivery devices.
12 Global
R&D Centers
Mylan recognizes that water is a scarce resource in many of the communities where our employees live and the company does business. We work proactively to protect water and reduce consumption. While we have made significant headway in reduction at some locations, our water usage in 2017 increased by 3.5% to 3.3 million cubic meters, due primarily to increased global production. We continually look for ways to reduce water consumption, reuse water for non-potable purposes and install technologies that ensure adequate quality wastewater.
We continue to invest in wastewater treatment facilities and look for additional improvements across our operations. For example, we recently installed a state-of-the-art, full-scale wastewater treatment system in our manufacturing facility in Galway, Ireland.